NSW Premier Mike Baird and Minister for Medical Research Pru Goward today announced that a Memorandum of Understanding (MOU) has been signed with GW Pharmaceuticals (GW) to progress a major new research program for cannabis-based medicines in children with severe, drug resistant childhood epilepsy.
“This confirms NSW’s position as a world leader on medicinal cannabis and demonstrates the determination of our Government to ensure we secure these groundbreaking trials,” Mr Baird said.
“Our research and development is driven by compassion for those suffering so we hope that these initiatives will bring relief to many children and their loved ones.”
Ms Goward said that this MOU is a historic achievement for our state.
“Our most vulnerable children will have access to these innovative and advanced drugs,” Ms Goward said.
The MOU between the NSW Government and GW Pharmaceuticals, comes as part of the NSW Government’s $21 million commitment to support medicinal cannabis reforms.
GW is a world leader in the research and development of novel cannabis-based prescription medicines and has more than 17 years of cannabinoid research experience.
The MOU will facilitate:
- A world first, phase 2 clinical trial in children for GW’s novel product containing the cannabinoid cannibidivarin (CBDV)
- A compassionate access scheme for Epidiolex®, GW’s product containing cannabidiol (CBD) which is currently in late stage trials in childhood epilepsy in the United States
- Provision for NSW to host additional phase 3 clinical trials of EpidiolexÒ in children with treatment-resistant epilepsy
- A phase 4 clinical trial of Epidiolex based on phase 3 studies
About the CBDV TRIAL
The NSW Government is providing $3.5 million to the Sydney Children's Hospitals Network to lead this world first, phase 2 clinical trial of CBDV in children, which will commence in 2016.
CBDV is a molecule in the cannabis plant that has shown promising results as an anti-convulsant, and for which GW Pharmaceuticals already has phase 1 clinical trial results in adults. CBDV does not produce the psychoactive effects associated with herbal cannabis.
“The phase 1 testing was carried out in healthy adults with no significant side effects, and we’re now ready to progress to phase 2 in children and have chosen to do this in NSW,” GW CEO Justin Gover said.
SCHN spokesperson Dr John Lawson said: “Pre-clinical studies have shown that CBDV has significant promise as an anti-epileptic agent.”
Epidiolex® is a product developed by GW, which contains the non-psychoactive cannabinoid, CBD. Epidiolex® is taken in the form of an oral liquid and is currently in Phase 3 trials internationally. Epidiolex® has shown positive results in a compassionate use program in the United States. To date, Australian children have had great difficulty accessing this drug.
The MOU delivers a compassionate access scheme for EpidiolexÒ for a small number of children who are too sick to participate in a clinical trial, due to the unrelenting nature of their epilepsy.
The partnership between the NSW Government and GW Pharmaceuticals also means NSW could host groundbreaking additional trials in the future. GW Pharmaceuticals is planning an international phase 3 clinical trial in 2016 for children with Tuberous Sclerosis Complex, a rare childhood epilepsy syndrome, as well as a phase 2 clinical trial for children with another form of treatment resistant epilepsy. GW has indicated their preference for NSW to be a site for these trials.
The MOU also includes a phase 4 clinical trial of Epidiolex® for children with severe, drug resistant epilepsy. The trial will be led by clinicians at the Sydney Children’s Hospitals Network. The goal will be to gather local medication safety data which will support an application to the Australian Therapeutic Goods Administration to make the product more widely available, if it is proven effective.
Public enquiries about the trial ring 1800 217 257.